ER+ and AR+ Breast Cancer
Conditions
Brief summary
This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.
Interventions
DRUGGTx-024 9 or 18 mg
Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
Sponsors
GTx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. In screening for, and ultimately randomized into, protocol G200802 2. Give voluntary, written and signed, informed consent for this add-on study 3. Age 18 to 70 years old 4. Physically capable of mounting and riding a stationary bicycle 5. Subject agrees to not significantly alter physical activity or current physical training during the study period
Exclusion criteria
1. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator 2. Subjects unwilling to or unable to comply with the protocol 3. Any other condition which per investigators' judgement may increase subject risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Power Production | 24 Weeks | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Power Production, Scaled to Lean Body Mass | 24 Weeks | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to LBM, as assessed by inertial-load cycle ergometry |
| Optimal Pedaling Rate | 24 Weeks | Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate |
| Lean Body Mass | 24 Weeks | Describe the effect of 24 weeks of treatment of GTx-024 on lean body mass (LBM) as assessed by CT images of the lumbar region from L3 to the iliac crest |
| Maximal Power Production, Scaled to Total Body Mass | 24 Weeks | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to total body mass (TBM), as assessed by inertial-load cycle ergometry |
| Maximal Power Production | 12 Weeks | Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Objective | 24 Weeks | Describe the impact of baseline measures and measures obtained throughout the study on maximal power production and its change from baseline |
Countries
United States
Outcome results
None listed